Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance replaces the agency's similarly-titled April 2022 draft guidance and has been issued to satisfy a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA) that the agency update or issue new draft guidance on the format and content of Diversity Action Plans. Under FDORA, Diversity Action Plans will be required for Phase 3 or other pivotal trials for drugs and for most device clinical trials, although some Diversity Action Plans for device trials can be first submitted with a marketing application such as a premarket notification where an investigational device exemption (IDE) is not required for the trial.
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